Validation Engineer Job at CSIRO (Melbourne)

Validation Engineer

CSIRO

Location:
Australia , Melbourne

Category:
Manufacturing

Contract Type:
Not provided

Salary:

100103.00 - 113251.00 AUD / Year

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Job Description:

Provide technical validation and engineering expertise to the Regulated Operations team within CSIRO’s Biomedical Manufacturing project, part of the National Vaccine and Therapeutics Laboratories. Supporting GMP‑compliant manufacturing and Quality Control facilities, this role is central to resolving TGA compliance findings and ensuring systems, documentation and practices meet cGMP requirements ahead of re‑inspection.

Job Responsibility:

Lead and support qualification and validation (IQ/OQ/PQ) of equipment, utilities and systems, including lifecycle documentation in line with GMP requirements
Ensure operational compliance with GMP, EHS and internal SOPs, including authoring and maintaining documentation such as deviations, CAPAs, SOPs and change controls
Support internal and external audits and inspections, including preparation of operational and technical information
Provide facility, plant and equipment troubleshooting, coordinating with internal teams and external vendors to resolve issues and support preventative maintenance
Collaborate closely with Manufacturing, Quality Assurance, Quality Control and Operations teams to support efficient and compliant facility operations
Apply risk‑based assessments (e.g. FMEA, HAZOP) to improve operational and validation outcomes

Requirements:

Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience
Demonstrated experience with operation, validation and/or management of GMP-regulated pharmaceutical manufacturing facilities, plants and equipment
Experience with facility systems (HVAC, clean utilities, EMS etc) and Equipment Qualification/Validation
Strong understanding of GMP, validation principles, and regulatory expectations (TGA, FDA etc)

Nice to have:

Experience working in regulated manufacturing environments, preferably supporting early‑phase clinical trial manufacturing, with demonstrated knowledge of GMP standards and electronic quality management systems (e.g. TrackWise, Veeva, ACE)
Demonstrated experience implementing, managing and validating operational procedures, facilities, and equipment, including Environmental Monitoring (EM) programs and Computer Systems Validation (CSV) for manufacturing and quality‑related systems
Experience supporting regulatory compliance activities, including participation in regulatory or internal audits and the ability to present operational and technical information to auditors
Strong problem‑solving and analytical skills, with demonstrated application of risk management tools such as FMEA and HAZOP to identify, assess and mitigate operational risk

What we offer:

15.4% superannuation
Options for part-time, job-share and flexible work arrangements can be discussed
Range of leave entitlements, benefits and career development opportunities

Additional Information:

Job Posted:
April 11, 2026

Expiration:
April 12, 2026

Work Type:

On-site work

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